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Invasive Breast CarcinomaNCT02276443

Molecular Testing and Imaging in Improving Response in Patients With Stage I-III Triple-Negative Breast Cancer Receiving Chemotherapy MDACC Breast Moonshot Initiative

A study testing Chemotherapy, Immunotherapy and Laboratory Biomarker Analysis in people with Invasive Breast Carcinoma and Stage I Breast Cancer AJCC v7, run by M.D. Anderson Cancer Center at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This clinical trial assesses whether a newly designed algorithm which looks at the genomic signature of each patient's tumor to predict their sensitivity to standard of care treatment verses being placed on a personally designed treatment trial can improve the responses in patients with newly diagnosed triple-negative… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Chemotherapy, Immunotherapy and Laboratory Biomarker Analysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
798 participants
Where
5 sitesUnited States
Study dates
9 Nov 2015to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient can undergo biopsy or surgery of a primary tumor site for suspected or proven invasive breast cancer of clinical stage I to III and are planned to receive neoadjuvant therapy with anthracycline/taxane based regimens (Arm A and Arm B) or chemotherapy/immunotherapy-based regimens (Arm C)
  • The patient was proven to have TNBC, defined from standard pathologic assays as negative for ER and PR (< 10% tumor staining) and negative for HER2 (immunohistochemistry [IHC] score < 3, gene copy number not amplified)
  • Patients must have left ventricular ejection fraction (LVEF) >= 50% by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) within 12 weeks prior to starting adriamycin
  • Leukocytes > 3,000/mcL
  • Absolute neutrophil count > 1,500/mcL
  • Platelets > 100,000/mcL
Show all 11Show fewer
  • Total bilirubin =< 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x institutional upper limit of normal
  • Creatinine within 1.5 X the upper limits of normal OR creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • For Arms A and B, patients must be medically ineligible to receive immunotherapy in combination with anthracycline/taxane-based chemotherapy as part of standard care
  • For Arm C, patients must be medically eligible to receive immunotherapy in combination with chemotherapy as part of standard of care

Who cannot join

  • The patient has diagnosis of stage IV disease or is found to have stage IV disease prior to initiation of chemotherapy
  • Prior history of invasive cancer within 5 years of study entry or history of metastatic cancer; exceptions include non-metastatic, curatively treated basal and squamous cell carcinoma of the skin
  • Prior excisional biopsy of the primary invasive breast cancer
  • Patients with hematomas or biopsy site changes that limit response assessment of the primary tumor by diagnostic imaging
  • Patients not eligible for chemotherapy with taxane and/or anthracycline based chemotherapy regimens
  • Prior therapy with - chemotherapy and/or immunotherapy
Show all 11Show fewer
  • Grade II or higher neuropathy
  • Patients with Zubrod performance status of > 2
  • Patients with history of serious cardiac events defined as:
  • Patients with a history of New York Heart Association class 3 or 4 heart failure, or history of myocardial infarction, unstable angina or cerebrovascular accident (CVA) within 6 months of protocol registration
  • Patients who have history of PR prolongation (grade 2 or higher) or atrioventricular (AV) block

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • MD Anderson in The Woodlands

    Conroe, Texas, 77384

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • MD Anderson West Houston

    Houston, Texas, 77079

  • MD Anderson League City

    League City, Texas, 77573

  • MD Anderson in Sugar Land

    Sugar Land, Texas, 77478

Other trials in United States

About this study

Official title: ARTEMIS: A Robust TNBC Evaluation FraMework to Improve Survival

This clinical trial assesses whether a newly designed algorithm which looks at the genomic signature of each patient's tumor to predict their sensitivity to standard of care treatment verses being placed on a personally designed treatment trial can improve the responses in patients with newly diagnosed triple-negative breast cancer (TNBC). Testing the primary tumor biopsy for certain proteins and monitoring the lymphocyte infiltration into the tumors may help doctors determine the sub-type of TNBC, and direct treatments that may work well. It is not yet known whether assigning treatment based on the patient's tumor classification will improve how well the tumor responds.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To conduct a prospective single arm, non-randomized trial to determine the impact of implementation of a research platform that includes diagnostic imaging to assess response to the initial phase of neoadjuvant chemotherapy combined with subtyping of TNBC in order to select the appropriate targeted therapy trial to complete neoadjuvant chemotherapy in patients found to have chemo-insensitive disease by imaging.

SECONDARY OBJECTIVES:

  1. Measured as defined by Standardized Definitions for Efficacy End Points (STEEP) criteria using the following prioritization: distant recurrence free interval (DRFI), recurrence free survival (RFS), distant relapse-free survival (DRFS), overall survival (OS), invasive disease free survival (IDFS), disease free survival including ductal carcinoma in situ (DFS-DCIS).

II. Evaluate the rates of enrollment into clinical trials for patients identified as having chemotherapy insensitive disease.

III. Evaluate the frequency of pathologic response rates (pCR, RCB I-III residual disease) in patients identified as chemotherapy sensitive versus insensitive.

IV. Determine the estimates of DRFI, RFS, DRFS, IDFS and DFS-DCIS at 3 years, and OS at 5 and 10 years in all patients.

  1. Determine the pathologic response based on molecular characterization. XI. Determine the estimates of DRFI, RFS, DRFS, IDFS and DFS-DCIS at 3 years, and OS at 5 and 10 years.

XII. Subset analyses of pathologic response and 3-year DRFI, RFS, DRFS, IDFS, and DFS-DCIS.

XIII. Compare the results of pathologic node-negative status (sentinel and/or non-sentinel nodes) after neoadjuvant chemotherapy according to a genomic predictor of nodal response to NACT, in subsets defined by pre-treatment clinical nodal status.

EXPLORATORY OBJECTIVES:

  1. Future re-analysis of residual samples using a customized genomic diagnostic platform (integrated "prospective-retrospective" biomarker analysis) to predict chemotherapy sensitivity.

II. Generation and subsequent molecular characterization of patient derived xenograph (PDX) models.

III. Clinical diagnostic development studies using residual samples (fresh and/or formalin-fixed) within the Clinical Laboratory Improvement Amendments (CLIA)-compliant Molecular Diagnostics Laboratory, and patient derived xenographs (PDX) to formally evaluate the clinical validity and utility of future clinical genomic diagnostic tests that would predict both response, recurrence, and survival from the treatments used in this clinical trial (correlative "retrospective-prospective" biomarker analyses).

IV. Correlative science studies to identify molecular therapeutic targets for treatment-insensitive TNBC using residual samples and PDX models.

  1. Correlation of tumor features or changes as measured by diagnostic imaging to determine potential predictors of treatment response.

VI. Determine polymerase chain reaction (pCR) rates in a cohort of patients who undergo surgical resection after achieving complete radiological response after 4 cycles of adjuvant chemotherapy (AC).

OUTLINE: Patients are assigned to 1 of 3 arms.

ARM A: Patients undergo baseline molecular and immunohistochemistry (IHC) evaluation of their tumor biopsy, and receive the results. Patients then receive standard anthracycline-based chemotherapy and undergo standard ultrasound at baseline, after 2 cycles, after 4 cycles of treatment, and after completion of treatment (before surgery). Patients and physicians are notified of the results of the molecular evaluation. Patients may then choose to continue with standard taxane +/- platinum-based chemotherapy or participate in an experimental clinical trial designed to match the molecular profile and triple-negative subtype. Patients with tumors predicted to be insensitive to chemotherapy are advised to participate in a clinical trial treating their tumor subtype.

ARM B: Patients undergo baseline molecular and IHC evaluation of their tumor biopsy, and receive the results. Patients then receive standard anthracycline-based chemotherapy and undergo standard ultrasound at baseline, after 2 cycles, and after 4 cycles of treatment. Patients and physicians are notified of the results of the molecular evaluation. Patients may then choose to continue with standard taxane +/- platinum-based chemotherapy or participate in an experimental clinical trial designed to match the molecular profile and triple-negative subtype. Patients with tumors predicted to be insensitive to chemotherapy are advised to participate in a clinical trial treating their tumor subtype.

ARM C: Patients undergo baseline molecular and IHC evaluation of their tumor biopsy, and receive the results. Patients then receive standard anthracycline-based chemotherapy with immunotherapy and undergo standard ultrasound at baseline, after 2 cycles, and after 4 cycles of treatment. Patients and physicians are notified of the results of the molecular evaluation. Patients may then choose to continue with standard taxane +/- platinum-based chemotherapy or participate in an experimental clinical trial designed to match the molecular profile and triple-negative subtype. Patients with tumors predicted to be insensitive to chemotherapy are advised to participate in a clinical trial treating their tumor subtype.

After completion of study treatment, patients are followed up for up to 5 years.

Being tested
Chemotherapy, Immunotherapy, Laboratory Biomarker Analysis, Lymph Node Biopsy, Ultrasonography
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChemotherapyDrug

    Also called Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General

    Receive standard chemotherapy

  • ImmunotherapyOther

    Also called Immunological, Immunological Therapy, Immunologically Directed Therapy

    Receive standard immunotherapy

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Lymph Node BiopsyProcedure or surgery

    Also called Biopsy of Lymph Node

    Undergo baseline lymph node evaluation

  • UltrasonographyProcedure or surgery

    Also called 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasound

    Undergo standard ultrasound

Study groups in NCT02276443
Study groupRoleWhat they receive
Arm A (predictive results given)ExperimentalPatients undergo baseline molecular and IHC evaluation of their tumor biopsy, and receive the results. Patients then receive standard anthracycline-based chemotherapy and undergo standard ultrasound at baseline, after 2 cycles, after 4 cycles of treatment, and after completion of treatment (before surgery). Patients and physicians are notified of the results of the molecular evaluation. Patients may then choose to continue with standard taxane +/- platinum-based chemotherapy or participate in an experimental clinical trial designed to match the molecular profile and triple-negative subtype. Patients with tumors predicted to be insensitive to chemotherapy are advised to participate in a clinical trial treating their tumor subtype.
Receives: Drug: Chemotherapy; Other: Laboratory Biomarker Analysis; Procedure: Lymph Node Biopsy; Procedure: Ultrasonography
Arm B (predictive results given)ExperimentalPatients undergo baseline molecular and IHC evaluation of their tumor biopsy, and receive the results. Patients then receive standard anthracycline-based chemotherapy and undergo standard ultrasound at baseline, after 2 cycles, and after 4 cycles of treatment. Patients and physicians are notified of the results of the molecular evaluation. Patients may then choose to continue with standard taxane +/- platinum-based chemotherapy or participate in an experimental clinical trial designed to match the molecular profile and triple-negative subtype. Patients with tumors predicted to be insensitive to chemotherapy are advised to participate in a clinical trial treating their tumor subtype.
Receives: Drug: Chemotherapy; Other: Laboratory Biomarker Analysis; Procedure: Lymph Node Biopsy; Procedure: Ultrasonography
Arm C (predictive results given)ExperimentalPatients undergo baseline molecular and IHC evaluation of their tumor biopsy, and receive the results. Patients then receive standard anthracycline-based chemotherapy with immunotherapy and undergo standard ultrasound at baseline, after 2 cycles, and after 4 cycles of treatment. Patients and physicians are notified of the results of the molecular evaluation. Patients may then choose to continue with standard taxane +/- platinum-based chemotherapy or participate in an experimental clinical trial designed to match the molecular profile and triple-negative subtype. Patients with tumors predicted to be insensitive to chemotherapy are advised to participate in a clinical trial treating their tumor subtype
Receives: Drug: Chemotherapy; Other: Immunotherapy; Other: Laboratory Biomarker Analysis; Procedure: Lymph Node Biopsy; Procedure: Ultrasonography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    A one-sided z-test will be used to compare the response rates of the treatment and control arms. The study will have 80% power to detect an increase in the response rate of 14.2 percentage points assuming a control arm response rate of 50% at the 0.05 significance level allowing for two interim tests for both futility and superiority.

    Measured: Up to 5 years

Secondary outcomes (2)

  1. Survival

    Will estimate the cumulative incidence function using Aalen-Johansen method with appropriate 96% confidence intervals.

    Measured: Up to 5 years

  2. Frequency of tumors

    Will estimate the relative frequency to triple negative breast cancer (TNBC) subsets (BRCA+, mesenchymal, androgen receptor [AR]+ and basal-like) classified withing each predication cohort and report both point estimates and simultaneous multinomial 95% confidence intervals based on the method of Goodman.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2014 (estimated)
  2. Study start9 Nov 2015
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
798 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02276443
Sponsor's protocol ID
2014-0185
Other IDs
NCI-2015-00191, 2014-0185, P30CA016672
Status last verified
Jul 2026
First submitted
21 Oct 2014
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Seth S, Yam C, Huo L, Lim B, Rinkenbaugh AL, White JB, Ravenberg EE, Song X, Litton JK, Tripathy D, Valero V, Damodaran S, Arun B, Ueno NT, Lucci A, Thompson AM, Mittendorf EA, Rauch GM, Adrada B, Candelaria RP, Ding Q, Powell RT, Abuhadra NK, Zhang J, Futreal A, Draetta GF, Piwnica-Worms H, Symmans WF, Chang JT, Moulder SL. The ARTEMIS trial identifies immune activation as a key predictor of neoadjuvant chemotherapy response in triple-negative breast cancer. Breast Cancer Res. 2026 May 6;28(1):120. doi: 10.1186/s13058-026-02290-z.

    PubMed 42093035

  • Wang X, Zhao L, Song X, Wu X, Krishnamurthy S, Semba T, Shao S, Knafl M, Coffer LW 2nd, Alexander A, Vines A, Bopparaju S, Woodward WA, Chu R, Zhang J, Yam C, Loo LWM, Nasrazadani A, Huong LP, Woodman SE, Futreal A; Rare Tumor Initiative Team; Tripathy D, Ueno NT. Genomic and transcriptomic analyses identify distinctive features of triple-negative inflammatory breast cancer. NPJ Precis Oncol. 2024 Nov 18;8(1):265. doi: 10.1038/s41698-024-00729-0.

    PubMed 39558017

  • Stowers CE, Wu C, Xu Z, Kumar S, Yam C, Son JB, Ma J, Tamir JI, Rauch GM, Yankeelov TE. Combining Biology-based and MRI Data-driven Modeling to Predict Response to Neoadjuvant Chemotherapy in Patients with Triple-Negative Breast Cancer. Radiol Artif Intell. 2025 Jan;7(1):e240124. doi: 10.1148/ryai.240124.

    PubMed 39503605

  • Basho RK, Zhao L, White JB, Huo L, Bassett RL, Mittendorf EA, Thompson A, Litton JK, Ueno N, Arun B, Lim B, Valero V, Tripathy D, Zhang J, Adrada BE, Santiago L, Ravenberg E, Seth S, Yam C, Moulder SL, Damodaran S. Comprehensive Analysis Identifies Variability in PI3K Pathway Alterations in Triple-Negative Breast Cancer Subtypes. JCO Precis Oncol. 2024 Mar;8:e2300124. doi: 10.1200/PO.23.00124.

    PubMed 38484209

  • Chen H, Ding Q, Khazai L, Zhao L, Damodaran S, Litton JK, Rauch GM, Yam C, Chang JT, Seth S, Lim B, Thompson AM, Mittendorf EA, Adrada B, Virani K, White JB, Ravenberg E, Song X, Candelaria R, Arun B, Ueno NT, Santiago L, Saleem S, Abouharb S, Murthy RK, Ibrahim N, Routbort MJ, Sahin A, Valero V, Symmans WF, Tripathy D, Wang WL, Moulder S, Huo L. PTEN in triple-negative breast carcinoma: protein expression and genomic alteration in pretreatment and posttreatment specimens. Ther Adv Med Oncol. 2023 Aug 2;15:17588359231189422. doi: 10.1177/17588359231189422. eCollection 2023.

    PubMed 37547448

  • Hwang KP, Elshafeey NA, Kotrotsou A, Chen H, Son JB, Boge M, Mohamed RM, Abdelhafez AH, Adrada BE, Panthi B, Sun J, Musall BC, Zhang S, Candelaria RP, White JB, Ravenberg EE, Tripathy D, Yam C, Litton JK, Huo L, Thompson AM, Wei P, Yang WT, Pagel MD, Ma J, Rauch GM. A Radiomics Model Based on Synthetic MRI Acquisition for Predicting Neoadjuvant Systemic Treatment Response in Triple-Negative Breast Cancer. Radiol Imaging Cancer. 2023 Jul;5(4):e230009. doi: 10.1148/rycan.230009.

    PubMed 37505106

  • Wu C, Jarrett AM, Zhou Z, Elshafeey N, Adrada BE, Candelaria RP, Mohamed RMM, Boge M, Huo L, White JB, Tripathy D, Valero V, Litton JK, Yam C, Son JB, Ma J, Rauch GM, Yankeelov TE. MRI-Based Digital Models Forecast Patient-Specific Treatment Responses to Neoadjuvant Chemotherapy in Triple-Negative Breast Cancer. Cancer Res. 2022 Sep 16;82(18):3394-3404. doi: 10.1158/0008-5472.CAN-22-1329.

    PubMed 35914239

  • Yam C, Abuhadra N, Sun R, Adrada BE, Ding QQ, White JB, Ravenberg EE, Clayborn AR, Valero V, Tripathy D, Damodaran S, Arun BK, Litton JK, Ueno NT, Murthy RK, Lim B, Baez L, Li X, Buzdar AU, Hortobagyi GN, Thompson AM, Mittendorf EA, Rauch GM, Candelaria RP, Huo L, Moulder SL, Chang JT. Molecular Characterization and Prospective Evaluation of Pathologic Response and Outcomes with Neoadjuvant Therapy in Metaplastic Triple-Negative Breast Cancer. Clin Cancer Res. 2022 Jul 1;28(13):2878-2889. doi: 10.1158/1078-0432.CCR-21-3100.

    PubMed 35507014

  • Yam C, Yen EY, Chang JT, Bassett RL, Alatrash G, Garber H, Huo L, Yang F, Philips AV, Ding QQ, Lim B, Ueno NT, Kannan K, Sun X, Sun B, Parra Cuentas ER, Symmans WF, White JB, Ravenberg E, Seth S, Guerriero JL, Rauch GM, Damodaran S, Litton JK, Wargo JA, Hortobagyi GN, Futreal A, Wistuba II, Sun R, Moulder SL, Mittendorf EA. Immune Phenotype and Response to Neoadjuvant Therapy in Triple-Negative Breast Cancer. Clin Cancer Res. 2021 Oct 1;27(19):5365-5375. doi: 10.1158/1078-0432.CCR-21-0144.

    PubMed 34253579

Questions about this trial

What is this clinical trial studying?

A study testing Chemotherapy, Immunotherapy and Laboratory Biomarker Analysis in people with Invasive Breast Carcinoma and Stage I Breast Cancer AJCC v7, run by M.D. Anderson Cancer Center at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02276443, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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